Irrigation/Urology Sets— 510(k) K254111

Name: FDA 510(k) clearance K254111
Creator: U.S. Food and Drug Administration
Published: 2026-09-10

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K254111 for Irrigation/Urology Sets, Substantially Equivalent on 2026-09-10. Applicant: B.Braun Medical, Inc.. Device class: 2.

Summary

B. Braun's Irrigation/Urology Sets are tubing sets for urological irrigation, filed under LJH, urological irrigation systems. They carry fluid from bags of irrigant to the scope or catheter during cystoscopy, TURP, and similar procedures.

Class II, 21 CFR 876.5130. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).

B. Braun Medical filed from Center Valley, Pennsylvania, its US headquarters. Review took 265 days (December 19, 2025 to September 10, 2026). The record doesn't list the individual set configurations.

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code LJH
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-19
Decision date: 2026-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.